Associate Director/Director
Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020
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Job Description:
Associate Director/Director, Global Medical Information Company:
Agios Pharmaceuticals Inc Location: Cambridge Posted on: September 12, 2020 Job Description: Associate Director/Director, Global Medical Information
LocationAgios Pharmaceuticals HQ Job Code 1263 # of openings 1 Associate Director/Director, Global Medical Information,
MedicalAffairs Agios (agios.com) is a biopharmaceutical company committed
toapplying our scientific leadership in cellular metabolism
totransform the lives of patients with cancer and rare
geneticdiseases. We are growing rapidly with an active research
anddiscovery pipeline across both therapeutic areas. Agios has
twoapproved oncology precision medicines and multiple
first-in-classinvestigational therapies in clinical and/or
preclinicaldevelopment. Agios Pharmaceuticals is searching for an
AssociateDirector/Director to join our growing Global Medical
Affairs team.The Associate Director/Director, Global Medical
Information willreport to the Senior Director of Scientific
Communications,Publications, and Medical Information and will be
responsible forsupporting all Agios pipeline or marketed products
and leading themanagement of medical information and related
activities.Responsibilities include but are not limited to: writing
standardresponse documents, answering escalated medical
informationqueries, oversee the activities of the medical
information callcenter, review content as a member of the Agios
Review Committee,participate in regulatory inspections and internal
audits. In thiscentral role, the Associate Director/Director will
engage withmultiple internal stakeholders such as Medical Affairs,
RegulatoryAffairs, Commercial, Market Access, Clinical Operations,
QualityAssurance, Medical Safety and Risk Management, Compliance
andLegal. Key Responsibilities Manage the Medical Information Call Center and provide
vendoroversight Provide ongoing training to the call center and other groups
asneeded (e.g. MSLs etc) on call- handling, newly launched
products,relevant disease states, Prescribing information,
important newpublications/data releases Conduct ongoing QA of call center case handling and
providetraining as needed Prepare reports on a quarterly basis related to frequent
topicsof inquiry in IDH program and PKR program;
presentfindings/trends/gaps at Medical Team meetings Participate in regulatory inspections and internal audits Prepare and plan for new product launches as needed Collaborate with Medical Science Liaisons, Publication
teams,Medical Safety and Risk Management, and Product Quality on
aregular basis Develop and update medical information standard
responsesummaries with new publications, congress data, press
releases,clinical trial information, etc; also includes FAQs, and
clinicaltrial scripts. Perform literature searches on a case by case basis asneeded Provide accurate, complete, and timely responses to
medicalinformation queries and/or direct call center to the proper
sourcefor that information or create customized responses
(literaturesearches) for US and ex-US requestors Develop in-depth knowledge on clinical data associated
withclinical trials, publications, and studies in Oncology,
Hematology,and Rare Genetic Diseases related to Agios programs Remain abreast of current FDA Guidelines as they relate
toMedical Information Integral member of the Agios Review Committee (ARC, med legalreg
review committee) Communicate relevant and timely clinical/economic evidence
onmarketed products to external customers (managed
careorganizations, public/private payers, pharmacy benefit
managers,specialty pharmacies etc) as well as providers who seek
medicalinformation to assist in overcoming reimbursement
barriers Oversee development of product dossiers for marketed
products;partner with HEOR Collaborate with Medical Information group at Celgene/BMS on
anongoing basis for co-developed products Attend and represent Medical Affairs at Congress booths
inOncology and RGD Participate in cross-functional Congress planning and overseethe
materials for the Medical Affairs/Medical Information sectionof the
exhibit Development, review, and update SOPs, guidance and
specialprojects as assigned Advanced degree preferred with 6+ years’ experience in
medicalinformation, medical affairs or applicable experience
working inpharmaceutical environment with transferrable skill
set Strong project management skills and leadership poise a must
tonegotiate and facilitate alignment amongst
internalstakeholders Ability to work with teams and manage vendors to ensureefficient
and compliant handling of medical informationservices Ability to create and oversee a budget Excellent and effective interpersonal and
communicationskills Must be well organized and able to multi-task in a
fast-paceddeadline driven environment Ability to understand and interpret regulations and
guidelinesgoverning publications and medical communications (e.g.
FDA, OIG,GPP3, ICJME) Advanced computer and Internet skills, including knowledge of
MSapplications such as Word, PowerPoint, and Excel; PubMed;
Referencedatabases Must be flexible and adaptable to meet the needs of a
rapidlygrowing organization Location: Any Ability to travel (US and International) approximately 20%
oftime Keywords: Agios Pharmaceuticals Inc, Cambridge , Associate
Director/Director, Global Medical Information, Other , Cambridge,
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